DENVER, Feb. 18 /PRNewswire-FirstCall/ -- Myogen, Inc. (Nasdaq: MYOG), a
biopharmaceutical company focused on the discovery, development and
commercialization of small molecule therapeutics for the treatment of
cardiovascular disorders, today reported 2003 fourth quarter and full year
results. At December 31, 2003, the Company had cash, cash equivalents and
short-term investments of $114.3 million.
Net loss for the quarter ended December 31, 2003 was $15.2 million,
compared with $8.1 million during the same period in 2002. For the year ended
December 31, 2003, the Company reported a net loss of $43.1 million, compared
with $28.0 million for 2002.
"2003 was filled with significant accomplishments for our organization,"
said J. William Freytag, President and Chief Executive Officer of Myogen. "We
achieved several major goals in expanding our product portfolio, continuing
the clinical development of our product candidates, accelerating our R&D
efforts and securing additional financing. These accomplishments continue
Myogen's progress towards its goal of becoming a fully integrated
biopharmaceutical company with strong discovery, development and
commercialization capabilities. I would like to thank all of our staff for
their hard work in making the year so successful. We look forward to another
year of solid execution with a strategy we believe will enhance the long-term
growth of the company and value for our stockholders."
2003 Achievements
* Completed enrollment in EMOTE, the Company's Phase III trial of
enoximone capsules in patients with the most advanced stages of
chronic heart failure.
* In-licensed darusentan, a type-A selective endothelin receptor
antagonist with positive Phase II data in hypertension.
* Raised net proceeds of $39.9 million through the sale of additional
shares of Series D preferred stock.
* Completed AMB-220, our Phase II trial of ambrisentan in pulmonary
arterial hypertension.
* Established a research collaboration with the Novartis Institutes for
BioMedical Research, Inc.
* Raised net proceeds of $73.3 million through the completion of our
initial public offering of common stock.
Product Portfolio Update
Enoximone:
* ESSENTIAL I & II, the Company's pivotal Phase III studies of enoximone
capsules in patients with chronic heart failure, continue to progress
in line with expectations. We expect to complete the treatment phase
for both of these trials before the end of this year.
* EMOTE, our 200-patient Phase III label-expansion study of enoximone in
patients with the most advanced stage of chronic heart failure,
completed enrollment in July 2003 and the last patient completed
treatment on February 9, 2004. We plan to compile and analyze the
data from this study through March and release summary results shortly
thereafter. Upon completion of EMOTE, eligible patients were given
the opportunity to enroll in an open-label extension study, MY-028.
MY-028 is on going and may continue until commercial product is
available or we terminate the study.
* EMPOWER, an additional Phase III label-expansion study, began
enrollment in September 2003. The study is enrolling substantially
slower than anticipated and we intend to re-assess the viability of
the study at the end of the second quarter of this year.
Although we do not believe that EMOTE or EMPOWER will be required for
initial regulatory approval, we believe these studies may assist in regulatory
and post-approval marketing efforts.
Ambrisentan: In January, we announced the initiation of patient
enrollment in ARIES I & II, two pivotal Phase III trials of ambrisentan in
pulmonary arterial hypertension (PAH). We plan to provide guidance on the
estimated completion of enrollment for these trials when we announce first
quarter 2004 results. Upon completion of the ARIES trials, eligible patients
will be given the opportunity to enroll in an extension study.
Detailed results of AMB-220, the Phase II study of ambrisentan in PAH,
will be disclosed in an oral presentation at a mini-symposium, Emerging
Therapies for PAH, at the ATS 2004 International Conference in Orlando,
Florida in May of this year. Upon completion of AMB-220, eligible patients
were given the opportunity to enroll in an open-label extension study,
AMB-220E. AMB-220E is on going and may continue until commercial product is
available or we terminate the study.
Darusentan: We are finalizing the design of the Phase IIb trial that will
initiate our clinical evaluation of darusentan in patients with resistant
hypertension. We expect to begin the trial in 2004.
2003 Fourth Quarter and Full Year Financial Highlights
Perfan I.V. sales for the three months ended December 31, 2003 were
$774,000 versus $686,000 for the same period in 2002. Perfan I.V. sales in
2003 were $2.8 million versus $2.3 million in 2002. The increase was
primarily due to a favorable increase in the euro exchange rate as unit sales
showed only modest growth. The cost of Perfan I.V. sold as a percentage of
sales was 31.1% and 37.5% for the years ended December 31, 2003 and 2002,
respectively.
Research and development expenses, excluding stock-based compensation
expenses, increased 75.7% to $12.7 million from $7.3 million for the three
months ended December 31, 2003 and 2002, respectively. For the year, research
and development expenses, excluding stock-based compensation expenses,
increased 49.8% to $37.4 million from $24.9 million in 2002. The increase in
expenses for the year was primarily due to higher costs associated with
increased patient enrollment in the ESSENTIAL trials, preparation for the
initiation of the ARIES trials and licensing fees related to the in-licensing
of darusentan.
Selling, general and administrative expenses, excluding stock-based
compensation expenses, increased 93.2% to $1.8 million from $943,000 for the
three months ended December 31, 2003 and 2002, respectively. For the year,
selling, general and administrative expenses, excluding stock-based
compensation expenses, decreased 5.7% to $4.4 million from $4.6 million in
2002. The decrease for the year was primarily associated with a decrease in
consulting, relocation and travel costs partially offset by an increase in
insurance costs related to becoming a public company.
2004 Milestones
Myogen previously announced milestones for 2004, including:
* Initiation of ARIES I & II (ambrisentan Phase III), which the Company
announced in January;
* Completion of EMOTE (enoximone Phase III) with summary results to be
reported in the first half of the year;
* Initiation of a Phase IIb trial of darusentan in resistant
hypertension; and
* Completion of patient enrollment and drug treatment in ESSENTIAL I &
II (enoximone Phase III) by the end of the year.
2004 Financial Guidance
Financial projections entail a high level of uncertainty due, among many
factors, to the variability involved in predicting clinical trial enrollment
rates, availability, terms and timing of additional financing transactions and
the potential for Myogen to enter into additional licensing or strategic
collaborations. The Company plans on updating financial guidance for 2004
when it releases results for each quarter or upon the announcement of material
corporate events.
For the year ending December 31, 2004, the Company presently anticipates:
* Total product sales of $2.3 million to $2.8 million;
* Total operating expenses, excluding stock-based compensation expenses,
of $66 million to $78 million; and
* Net loss per share between $2.46 and $2.92.
In addition, we believe our current cash, cash equivalents and short-term
investments are sufficient to fund the Company's operations through the middle
of next year.
Conference Call
J. William Freytag, President and CEO, and other members of Myogen's
senior management will review fourth quarter and full year results via webcast
and conference call on Wednesday, February 18, 2004 at 4:15pm Eastern. To
access the live webcast, please log on to the company's website at
http://www.myogen.com and go to the Investor Relations section. Alternatively,
callers may participate in the conference call by dialing 800-218-0713
(domestic) or 303-262-2141 (international). Webcast and telephone replays of
the conference call will be available approximately two hours after the
completion of the call through Friday, February 27, 2004. Callers can access
the replay by dialing 800-405-2236 (domestic) or 303-590-3000 (international).
The pass code is 568765#.
About Myogen
Myogen is a biopharmaceutical company focused on the discovery,
development and commercialization of small molecule therapeutics for the
treatment of cardiovascular disorders. Myogen currently markets one product
in Europe for the treatment of acute decompensated heart failure and is
developing three product candidates for three distinct cardiovascular
indications. The Company also conducts a target and drug discovery research
program focused on the development of disease-modifying drugs for the
treatment of chronic heart failure and related cardiovascular disorders.
Please visit our website at http://www.myogen.com.
Safe Harbor Statement
This press release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed in this release
and others that can be found in the "Risk Factors" section of Myogen's
Prospectus filed on October 30, 2003 and in our Form 10-Q filed on December 4,
2003. Myogen is providing this information as of the date of this release and
does not undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future events or
otherwise.
The Company cautions investors not to place undue reliance on the
forward-looking statements contained in this press release. No
forward-looking statement can be guaranteed and actual events and results may
differ materially from those projected. The Company's results may be affected
by its effectiveness at managing its financial resources, its ability to
successfully develop and market current and new products, difficulties or
delays in its clinical trials, difficulties or delays in manufacturing its
products, and regulatory developments involving current and future products.
Delays in clinical trials, whether caused by adverse events, patient
enrollment rates, regulatory issues or other factors, could adversely affect
the Company's financial position and prospects. Results from earlier clinical
trials are not necessarily predictive of future clinical results. If the
Company is unable to raise additional capital when required or on acceptable
terms, it may have to significantly delay, scale back or discontinue one or
more of its drug development or discovery research programs. Myogen is at an
early stage of development and may not ever have any products that generate
significant revenue.
MYOGEN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
December 31,
2003 2002
ASSETS
Current assets:
Cash, cash equivalents and short-term
investments $114,252,348 $33,797,765
Other current assets 5,665,710 2,620,405
Total current assets 119,918,058 36,418,170
Property and equipment, net 1,304,028 1,691,931
Other assets 51,238 33,590
Total assets $121,273,324 $38,143,691
LIABILITIES, MANDATORILY REDEEMABLE CONVERTIBLE PREFERRED STOCK
AND STOCKHOLDERS' EQUITY/(DEFICIT)
Current liabilities:
Accounts payable $7,594,935 $2,748,647
Other current liabilities 4,693,042 1,918,074
Total current liabilities 12,287,977 4,666,721
Other liabilities 5,063,552 3,740,022
Mandatorily redeemable convertible preferred
stock -- 106,565,591
Stockholders' equity/ (deficit):
Common stock and preferred stock 26,458 1,829
Additional paid-in capital 229,080,380 --
Deferred stock-based compensation (6,730,195) (1,726,692)
Other comprehensive income 22,185 225,420
Deficit accumulated during the
development stage (118,477,033) (75,329,200)
Total stockholders' equity/(deficit) 103,921,795 (76,828,643)
Total liabilities, mandatorily
redeemable convertible preferred
stock and stockholders' equity/
(deficit) $121,273,324 $38,143,691
MYOGEN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Year ended Three months ended
December 31, December 31,
2003 2002 2003 2002
Revenues:
Product
sales $2,845,713 $2,342,899 $773,890 $685,771
Research and
development
contracts 1,010,305 -- 1,010,305 --
3,856,018 2,342,899 1,784,195 685,771
Costs and
expenses:
Cost of
product sold 885,145 877,434 231,007 216,433
Research and
development
(excluding
stock-based
compensation
expense of
$2,372,888,
$430,838,
$1,129,027
and $223,637,
respectively)37,364,578 24,949,510 12,742,617 7,250,802
Selling,
general and
administrative
(excluding
stock-based
compensation
expense of
$1,819,368,
$250,405,
$956,927 and
$143,435,
respectively) 4,386,635 4,649,830 1,822,326 943,286
Stock-based
compensation 4,192,256 681,243 2,085,954 367,072
46,828,614 31,158,017 16,881,904 8,777,593
Loss from
operations (42,972,596) (28,815,118) (15,097,709) (8,091,822)
Interest
(expense)
income, net (135,891) 785,843 (72,512) 41,740
Loss before
income taxes (43,108,487) (28,029,275) (15,170,221) (8,050,082)
Income taxes 39,346 18,304 23,181 7,525
Net loss (43,147,833) (28,047,579) (15,193,402) (8,057,607)
Accretion of
mandatorily
redeemable
convertible
preferred
stock (13,187,174) (14,683,739) (1,603,187) (3,670,934)
Deemed
dividend
related to
beneficial
conversion
feature of
preferred
stock
(Note 1) (39,935,388) -- -- --
Net loss
attributable
to common
stockholders $(96,270,395) $(42,731,318) $(16,796,589) $(11,728,541)
Basic and
diluted net
loss per
common share $(17.79) $(42.59) $(0.91) $(11.48)
Weighted average
common shares
outstanding
(Note 2) 5,411,891 1,003,426 18,408,150 1,021,518
Notes:
(1) Deemed dividend related to beneficial conversion feature of preferred
stock is calculated as the difference between the Series D preferred stock
offering price and the estimated fair value of the Series D preferred
stock, limited to the amount of proceeds from the sale of the Series D
preferred stock. The Company's historical capital structure is not
indicative of its current structure due to the automatic conversion of all
shares of the then outstanding preferred stock into common stock
concurrent with the closing of the Company's initial public offering.
(2) In November 2003, the Company sold 5,750,000 common shares for net
proceeds of $73.3 million in its initial public offering. Concurrently,
19,604,186 common shares were issued upon the conversion of the Series A,
B, C and D preferred stock. Accordingly, this was the cause for the
increase in the weighted average common shares outstanding for the three
months and year ended December 31, 2003.
SOURCE Myogen, Inc.
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Related links:
http://www.myogen.com
CONTACT:
Derek K. Cole, Director, Investor Relations,
+1-303-464-3986, derek.cole@myogen.com; or Joseph L. Turner,
Chief Financial Officer, +1-303-464-5222, joe.turner@myogen.com,
both of Myogen, Inc.
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